drugset / Trial / NCT04065529

Clinical Trial in Children Between 3 Months and 14 Years Old to Evaluate the Efficacy and Safety of Gelatin Tannate in the Treatment of Acute Diarrhea (INDIGO)

NCT04065529

Phase 3 Completed 150 enrolled Ferrer Internacional S.A. Axonal-Biostatem · collab
RandomizedParallel-groupTriple-blindTreatment

Summary

To evaluate the safety, global efficacy and rapidity of action of GT in children with acute gastroenteritis taking ORS solution.

Timeline

Start
2019-09-11
Primary completion
2020-06-11
Completion
2020-06-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Gelatin Tannate Other / unclassified 1 unknown
Subject Gelatin Tannate Other / unclassified 2 unknown
Background Zinc supplementation Unknown
Background oral rehydration solution Unknown Oral

Indications